Healthy Men and WomenNCT01836887
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health(2)
A study testing Polyphenol-enriched fruit-based drink - low and Polyphenol-enriched fruit-based drink - high in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Polyphenol-enriched fruit-based drink - low and Polyphenol-enriched fruit-based drink - high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged from 45 to 60 years old, on the day of inclusion
- Able to understand the information sheet and comply with all the trial procedures
- Having given written consent to take part in the study prior to participation.
- Body mass index (BMI): 18.0 - 35 kg/m².
Who cannot join
- Those diagnosed with Phenylketonuria (PKU)
- Those with known or suspected food intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast feeding
- Participation in another clinical trial
- Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months
Show all 17Show fewer
- Those with Full Blood Counts and Liver Function test results outside of the normal range
- Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
- Current smokers, or reported giving up smoking within the last 6 months
- History of substance abuse or alcoholism
- Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
- Unwilling to restrict consumption of specified high polyphenol foods for 24 h before the study
- Weight loss >3kg in preceding 2 months and body mass index <18 or >35 kg/m²
- Blood pressure ≥160/100 mmHg
- Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
- Medications that may interfere with the study such as alpha-glucosidase inhibitors (e.g. acarbose), insulin-sensitising drugs (e.g. metformin, thiazolidinediones), sulfonylureas, and lipid-lowering drugs. Other medications, should be reviewed by medical representative from KCL on a case by case basis.
- Nutritional supplements that may interfere with the study such as higher dose vitamins/minerals (>200% RNI), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100 % or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes & Nutritional Sciences Division, School of Medicine, King's College London
London, SE1 9NH
About this study
Official title: Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications (Phase 2)
The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.
- Conditions
- Healthy Men and Women
- Being tested
- Very low polyphenol fruit based drink (control), Polyphenol-enriched fruit-based drink - low, Polyphenol-enriched fruit-based drink - high
- Keywords
- Polyphenol, Fruit, Metabolic, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low polyphenol fruit based drink (control)Dietary supplement
Polyphenol-enriched fruit-based drink - lowDietary supplement
Polyphenol-enriched fruit-based drink - highDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Placebo comparator | Very low polyphenol fruit based drink (control) Receives: Dietary Supplement: Very low polyphenol fruit based drink (control) |
| Intervention 2 | Active comparator | Polyphenol-enriched fruit-based drink - low Receives: Dietary Supplement: Polyphenol-enriched fruit-based drink - low |
| Invervention 3 | Active comparator | Polyphenol-enriched fruit-based drink - high Receives: Dietary Supplement: Polyphenol-enriched fruit-based drink - high |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic health
Postprandial metabolic response
Measured: Postprandial response (2hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836887
- Sponsor's protocol ID
- TSB101118 (2)
- Other IDs
- Technology Strategy Board
- Status last verified
- Sep 2019
- First submitted
- 12 Apr 2013
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications (Phase 2)
- ClinicalTrials.gov ID
- NCT01836887
- Acronym / sponsor ID
- TSB101118 (2)
- Conditions
- Healthy Men and Women
- Keywords
- Polyphenol, Fruit, Metabolic, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Lucozade Ribena Suntory
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Placebo comparator | Dietary Supplement: Very low polyphenol fruit based drink (control)Very low polyphenol fruit based drink (control) |
| Intervention 2 | Active comparator | Dietary Supplement: Polyphenol-enriched fruit-based drink - lowPolyphenol-enriched fruit-based drink - low |
| Invervention 3 | Active comparator | Dietary Supplement: Polyphenol-enriched fruit-based drink - highPolyphenol-enriched fruit-based drink - high |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged from 45 to 60 years old, on the day of inclusion
- Able to understand the information sheet and comply with all the trial procedures
- Having given written consent to take part in the study prior to participation.
- Body mass index (BMI): 18.0 - 35 kg/m².
Key exclusion criteria (17 listed)
- Those diagnosed with Phenylketonuria (PKU)
- Those with known or suspected food intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast feeding
- Participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low polyphenol fruit based drink (control) | Dietary supplement | Intervention 1 |
| Polyphenol-enriched fruit-based drink - low | Dietary supplement | Intervention 2 |
| Polyphenol-enriched fruit-based drink - high | Dietary supplement | Invervention 3 |
Primary outcome
Metabolic health
Time frame: Postprandial response (2hrs)
Postprandial metabolic response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- ThesisLink provided by the sponsor.
Related trials for Healthy Men and Women
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
Active, not recruitingPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Healhty, Overweight or Obesity
Recruiting
Long-Term Effects of Walnut Consumption on Brain Function
Healthy, Brain Insulin Sensitivity
Active, not recruitingEarly Phase 1
Investigation of the Distinct Mechanisms Involved in Inflammatory Resolution Between Healthy Men and Women
Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-enriched fruit-based drink - low and Polyphenol-enriched fruit-based drink - high in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic health (time frame: Postprandial response (2hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.